MULTIPLE MANUFACTURED BY PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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MULTIPLE

Request for Information Form	Contact Information
Company Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
Address	ROENTGENSTRASSE 24
City, State, Zip	HAMBURG,
Country	GM
FDA Owner/Operator Phone	425-487-7000
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	IZH
FDA Classification Name	SYSTEM, X-RAY, MAMMOGRAPHIC
FDA Device Classification Code	Standards
FDA Regulation Number	892.1710
FDA Common Generic Name	MAMMOGRAPHIC X-RAY SYSTEM
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1217116
FDA Owner / Operator Name	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
FDA Establishment Registration Number	3003768251
FDA Registered Establishment Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
FDA Operation Code(s)
FDA Listing Date	02-17-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AMERICAN MAMMOGRAPHICS, INC. 1302 SHAWHAN TERRACE CHATTANOOGA, TN 37411 US 423-624-9530 / 423-624-9530	MAMMOSPOT, S.O.F.T. PADDLE	MAMMOGRAPHIC ACCESSORIES, MAMMOGRAPHIC SPOT COMPRESSION PLATFORMS & PADDLE; SCRE
2	AR CUSTOM MEDICAL PRODUCTS, LTD. 20 SPINNER LANE COMMACK, NY 11725 US 866-242-7501 / 866-242-7501	MAMM-AIRE, MG30 MAMMOGRAPHY BUCKY, BUCKY	MAMMOGRAPHIC IMAGE RECEPTOR SUPPORT DEVICE
3	BAY SHORE MEDICAL EQUIPMENT CORP. 235 SOUTH FEHR WAY BAY SHORE, NY 11706 US 631-586-1991 / 631-586-1991	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
4	BIOLUCENT, INC. 6 JOURNEY, SUITE 325 ALISO VIEJO, CA 92656 US 949-349-1380 / 949-349-1380 102	MAMMOPAD	RADIOLUCENT X-RAY CUSHION
5	CINTEC MEDICAL LTD MATAM ADVANCED TECHNOLOGY CENTER HAIFA, 31905 IS 972-481-31415 / 972-481-31415	MULTIPLE	VARIOUS
6	COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE GEORGETOWN,ONTARIO, L7G 2J4 CA 905-877-0161 / 905-877-0161	PNEUMATIC COMPRESSION KIT	PNEUMATIC COMPRESSION KIT
7	DIAGNOSTIC IMAGING SPECIALISTS CORP. 163 ST. MALO ST. ST. MALO, MANITOBA, R0A1T0 CA	MULTIPLE	MAMMOGRAPHIC AEC CORRECTION CIRCUIT
8	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, 00510 FI 847-277-5002 / 262-544-3894	MULTIPLE (DIAMOND, PERFORMA, ALPHA, DELTA)	MAMMOGRAPHY X-RAY SYSTEMS
9	GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE BP 34 BUC CEDEX, 78533 FR 847-277-5002 / 262-544-3894	MULTIPLE	VARIOUS MODELS OF MAMMOGRAPHIC SYSTEMS
10	GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 847-277-5002 / 262-544-3894	MMX-2	MMX-2
11	GIOTTO USA, LLC 1822 EAST 1ST STREET WICHITA, KS 67214 US 316-393-5966 / 316-393-5966	VARIOUS: GIOTTO IMAGE, GIOTTO HT, AND ACCESSORIES	MAMMOGRAPHIC X-RAY SYSTEM
12	IMAGING DIAGNOSTIC SYSTEMS, INC. 6531 N.W. 18TH COURT PLANTATION, FL 33313 US 954-581-9800 / 954-581-9800 216	COMPUTED TOMOGRAPHY LASER MAMMOGRAPHY MODEL 1020	CTLM
13	INTERNAZIONALE MEDICO SCIENTIFICA (IMS) 5 VIA SAGITTARIO PONTECCHIO MARCONI BOLOGNA, 40044 IT 011-390-051846851 / 316-393-5966	GIOTTO	VARIOUS MODELS OF MAMMOGRAPHY SYSTEMS
14	LINEAR MEDICAL CORPORATION 1130 WEST 124TH AVENUE, SUITE 400 WESTMINSTER, CO 80234 US 303-962-5730 / 303-962-5730	MAMMOTEST	MAMMOGRAPHIC X-RAY SYSTEM
15	LIV INTERNATIONAL USA, INC. 2335 WEST FOOTHILL BLVD. SUITE 14 AND 15 UPLAND, CA 91784 US 909-931-1719 / 909-931-1719	LIV(TM) BREAST SELF EXAMINATION AID	LIV(TM) BREAST SELF EXAMINATION AID
16	LIVINGSTON PRODUCTS, INC. 260 HOLBROOK WHEELING, IL 60090 US 847-808-0900 / 847-808-0900	ADVANTAGE PADDLE	MAMMOGRAPHY COMPRESSION PADDLE
17	LORAD, A HOLOGIC CO. 37 APPLE RIDGE RD. DANBURY, CT 06810 US 781-999-7300 / 781-999-7368	VARIOUS MODELS	MAMMOGRAPHY X-RAY SYSTEM
18	LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. DANBURY, CT 06810 US 781-999-7300 / 781-999-7368	LORAD ELITE MAMMOGRAPHY SYSTEM	ELITE SYSTEM
19	MBF SALES, LLC 7025 E GREENWAY PARKWAY, #250 SCOTTSDALE, AZ 85254 US 480-422-6742 / 480-422-6742	MY BREAST FRIEND SELF-EXAM PAD	BREAST SELF-EXAM PAD
20	PLANMED OY ASENTAJANKATU 6 HELSINKI, 00880 FI 358-20-7795300 / 358-20-7795300	PLANMED SOPHIE	MAMMOGRAPHIC X-RAY UNIT
21	S & S X-RAY PRODUCTS INC., MASTERS DIVISION 1000 WEST PENNSYLVANIA AVE. PEN ARGYL, PA 18072 US 281-815-1300 / 516-482-9001	SQUEEZE-EASE MAMMOGRAPHY CUSHION	MAMMOGRAPHY COMPRESSION PAD/CUSHION
22	SCIENTIFIC BIOSPY LTD. 1 HAAZMAUT ST. EVEN YEHUDA, 40500 IS 972-989-91072 / 972-989-91072	BIOLITE	STEREOTACTIC BREAST BIOPSY SYSTEM
23	SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN, 91052 GM / 610-448-4153	MULTIPLE	MAMMOGRAPHY SYSTEM
24	SING YOUNG HONG LTD. 5F,#26 CHIN HWA STREET, CHING CHENG DIS TAIPEI,TAIWAN, CH 886-2-23937625 / 301-838-3120	MY BREAST FRIEND SELF EXAM PAD	BREAST SELF EXAM PAD
25	TRAXYZ MEDICAL, INC. 24 LIDO LANE BEDFORD, MA 01730 US 781-249-6254 / 781-249-6254	TRAXYLOC-1 SYSTEM	TRAXYLOC-1 SYSTEM